OMEPRAZOLE MAGNESIUM | A078878 | DR REDDYS LABORATORIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Mattingly, Stanger & Malur, P.C. - Citizen Petition FDA-2003-P-0224 · 4 docket documents The law firm Mattingly, Stanger & Malur, P.C. filed this citizen petition under 21 CFR 10.30 and 10.35(b) requesting that the FDA amend its NDA approval for Prilosec OTC (omeprazole magnesium), a nonprescription heartburn treatment approved on June 20, 2003, to require marketing under a different br | Other | 2009-01-05 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.3890
per ea
Lowest NADAC/Unit
$0.3890
per ea
Brand NDCs
0
Generic NDCs
8
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 55111039727OMEPRAZOLE MAG DR 20.6 MG CAP | $0.3890 | EA | Generic | — | 2026-06-17 |
| 55111039733OMEPRAZOLE MAG DR 20.6 MG CAP | $0.3890 | EA | Generic | — | 2026-06-17 |
| 55111039752OMEPRAZOLE MAG DR 20.6 MG CAP | $0.3890 | EA | Generic | — | 2026-06-17 |
| 83324011714OMEPRAZOLE MAG DR 20 MG CAP | $0.3890 | EA | Generic | — | 2026-06-17 |
| 83324011742OMEPRAZOLE MAG DR 20 MG CAP | $0.3890 | EA | Generic | — | 2026-06-17 |
| 70000023201ACID REDUCER DR 20 MG CAP | $0.3890 | EA | Generic | — | 2026-06-17 |
| 70000023202ACID REDUCER DR 20 MG CAP | $0.3890 | EA | Generic | — | 2026-06-17 |
| 70000023203ACID REDUCER DR 20 MG CAP | $0.3890 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.